Cleared Traditional

K200749 - CUBEScan BioCon-900S

K200749 is the FDA 510(k) clearance for CUBEScan BioCon-900S by Mcube Technology Co., Ltd.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K200749 · Mcube Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
57d
Days
Class 2
Risk

K200749 is an FDA 510(k) clearance for the CUBEScan BioCon-900S. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Mcube Technology Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on May 19, 2020 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mcube Technology Co., Ltd. devices

Submission Details

510(k) Number K200749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2020
Decision Date May 19, 2020
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 387
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K200749.
Liver Incytes, Model 1005
K201597 · Sonic Incytes · Jul 2020
FibroScan® 630
K200655 · Echosens · Jul 2020
Auto 3D Bladder Volume Tool
K200980 · Butterfly Network, Inc. · Jun 2020
CUBEScan BioCon-1100
K200548 · Mcube Technology Co., Ltd. · Mar 2020
Shear Wave Quantificational Ultrasound Diagnostic System
K200136 · Wuxi Hisky Medical Technologies Co., Ltd. · Mar 2020
SonicEye Dual-Array Ultrasound System
K192253 · Sonivate Medical, Inc. · Feb 2020